Trial document




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  DRKS00014260

Trial Description

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Title

Psychological protective and risk factors in infertile women and men before assisted reproductive treatment - a multicentre study in Germany, Austria and Switzerland

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Trial Acronym

D_A_CH study

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URL of the Trial

https://www.klinikum.uni-heidelberg.de/index.php?id=139867&L=1

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Brief Summary in Lay Language

Identification of psychological protective (e.g. self efficacy) and risk factors (e.g. depression, anxiety, missing social support, negative cognitions) in women and men before assisted reproductive treatment (first contact).

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Brief Summary in Scientific Language

The planned study is aimed to analyse two psychological factors and their correlations: emotional stability concerning self-efficacy (measured with the infertility self-efficacy scale ISE) and psychosocial risk factors as anxiety, depression, missing social support and negative cognitions (measured with the ScreenIVF), then analysed with the Actor-Partner-Interdependence-Model. Sociodemografic variables (e.g. age, duration of the wish for a child, educational level) and medical data (e.g. self-assessed medical diagnoses, ART (assisted reproductive technology) cycles, already existing children) will be assessed as potential moderator variables. This is a cross-sectional multicenter study with couples in five infertility clinics in Germany, Austria and Switzerland.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014260
  •   2018/03/22
  •   [---]*
  •   yes
  •   Approved
  •   S-123/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N97 -  Female infertility
  •   N46 -  Male infertility
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Interventions/Observational Groups

  •   Assessment of women and men before infertility treatment with questionnaires on self-efficacy (measured with the infertility self-efficacy scale ISE) and on psychosocial risk factors as anxiety, depression, missing social support and negative cognitions (measured with the ScreenIVF), then analysed with the Actor-Partner-Interdependence-Model.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Questionnaires on sociodemographic data (Soziodat), self-efficacy (Infertility Self-Efficacy Scale), and screening for psychological risk factors (ScreenIVF) of women and men with first contact in an fertility center.

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Secondary Outcome

n/a

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/05/01
  •   1000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

All couples undergoing assisted reproductive treatment in one of the five centers included in the study, who agreed to participate and who have sufficient knowledge of the German language. Only one of the two partners of a couple may also participate. The participants have to be at least 18 years old. Participants have to be competent persons.

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Exclusion Criteria

Exclusion criteria are persons not willing to participate, with insufficient knowledge of German or study drop-outs.

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Addresses

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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/05/15
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Trial Publications, Results and other Documents

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